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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 233 out of 8,010

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VAERS ID: 1765646 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Pyrexia, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Became very ill after receiving a pneumonia vaccine several years ago.
Other Medications: Trulicity, pantaprazole, pepcid, Zetia, vitamin D3, meloxicam, trazadone, tramadol, bentyl, belladonna elixir, pristiq
Current Illness:
Preexisting Conditions: Fibromyalgia, erosive arthritis, osteoarthritis, diabetes type 2, IBS, depression, anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: From 9/9/21 @ 1030 pm thru 9/23/2021, intermittent fever only reduced by Tylenol but continued to recur daily. Average 101.4. Constant diarrhea. Could not drink even water without getting sick. Lost 20 lbs in 21 days. Chronic fatigue and headaches.


VAERS ID: 1765889 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Anxiety, Blood test normal, Chest pain, Computerised tomogram normal, Dyspnoea, Electric shock sensation, Fear, Neuropathy peripheral, Pain, Peripheral swelling, Tachycardia, Ultrasound scan normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Occasional Motrin, Occasional Loreprazam 0.5 mg for Sleep.
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin
Diagnostic Lab Data: September 17, 2021 -- Ultrasound of Left leg and blood work. All normal. September 27, 2021-- More blood work and CT scan with Isotope. Again Normal results. Yet still experiencing daily issues.
CDC Split Type:

Write-up: Day After injection - lots of anxiety and tachycardia. 2 weeks after vaccine - swelling in the back of the left leg. Various heart pain and anxiety when I get the chest pain. 3 weeks after some shortness of breath. Throughout the month neuropathy in the legs. Zapping Random Pains. Having chest pain again tonight. Awful scary stuff happening to me.


VAERS ID: 1767105 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blood clot in left arm continued taking a daily aspirin


VAERS ID: 1767366 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30130SA / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Erythema, Extra dose administered, Heart rate, Hypersensitivity, Off label use, Pain in extremity, Peripheral swelling, Pruritus, Rash, Skin disorder, Urticaria, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ovarian cyst (Verbatim: Ovarian cyst); Psoriatic arthritis (Verbatim: Psoriatic arthritis); Type 1 diabetes mellitus (Verbatim: Type 1 Diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: Scorpion sting (Verbatim: Anaphylactic Reaction to scorpion sting); Seafood allergy (Verbatim: Anaphylactic Reaction to crab/shellfish); Shellfish allergy (Verbatim: Anaphylactic Reaction to crab/shellfish); TIA (Verbatim: TIA)
Allergies:
Diagnostic Lab Data: Test Name: Pulse; Result Unstructured Data: Test Result:70; Test Name: Pulse; Result Unstructured Data: Test Result:Okay; Comments: her pulse is okay
CDC Split Type: USPFIZER INC202101211960

Write-up: itching/Rash and itching all over./Ear itches; Hive dots adjoined her red neck, inside her ears.; Seemed to have gotten a little worse last night.; rash/Rash and itching all over./ Ear itches; The injection site was very swollen; Severe allergic reaction; received the booster dose of the Pfizer Covid 19 Vaccine; received the booster dose of the Pfizer Covid 19 Vaccine; Her arm swelled up, the swelling went all the way up to her ear and into her hair; arm was really sore as well; had dots, bumps, welts, on her chest, neck, abdomen, arms, armpits, down in the groin area, and her buttocks; had dots, bumps, welts, on her chest, neck, abdomen, arms, armpits, down in the groin area, and her buttocks; has a red, solid, raised area around her neck; This is a spontaneous report from a Pfizer-sponsored program Pfizer Support. A contactable consumer (patient''s husband) reported for a 75-year-old female patient. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 09Sep2021 (at the age of 75 years) (Batch/Lot Number: 30130SA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included ongoing type 1 diabetes, transient ischaemic attack from Dec2005 to Oct2017, Anaphylactic Reaction to crab/shellfish from an unknown date and unknown if ongoing, ongoing ovarian cyst, Psoriatic arthritis from Jul2021 and ongoing, Anaphylactic Reaction to scorpion sting from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for cerebrovascular accident from 2016 to an unspecified stop date. The patient previously took drug hydroxychloroquine in 2021 (Stated that his wife has stopped this medication. She did not take it the day of her third dose of the vaccine. She had been taking it at that time for around a month. She stopped taking it on either 07Sep2021 or 08Sep2021). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28-JAN-2021 as Dose 1, Single, dose 2 via an unspecified route of administration, administered in Arm Left dose 2 on 27Feb2021 as Dose 2, Single for covid-19 immunisation (at the age of 74 years). Caller (patient''s husband) on behalf of wife sated, Received third (booster) dose 09Sep2021. She had been having swelling, rash, itching. Swelling most in her arm. Rash and itching all over. Knew we cannot give any medical advice but wanted to know if there was a recommendation for something to help with the itching. Called her United Health Care Nurse Saturday antihistamine, soda baths. She''s improved a bit. Hive dots adjoined her red neck, inside her ears. Quintessential allergic reaction. Seemed to have gotten a little worse last night. Saw her doctor yesterday. Thought we were getting ahead of it over the weekend. He said Well, he had not seen it before. Pulse 70. Not having a breathing problem, not anything life threatening. Gave her aspercreme with lidocaine. Mixed oral gel with hydrocortisone to try to numb the nerves a little bit. "Keep going on the stocks", shareholder. Only redness on shots one and two, very little swelling. The injection site was very swollen. Can you tell me if that''s common? Are they experiencing more sensitivity in the third shot? You probably did not have info on the boosters yet? Have you had more luck with steroids, prednisone something like that? She didn''t take the hydro chloroquine for the Trumpian use of covid-19. She started it on 04 AUG2021 arthritis. She did take it the day of the injection. I saw online that someone had a very similar reaction with someone that was taking hydro chloroquine Lot Number 2106277C. Stated that his wife''s doctor had spoken about her having a hysterectomy for this condition. His wife was taking Bee Pollen with Aloe Juice and Honey as a form of self-treatment, had stopped taking it. The caller''s wife experienced a severe allergic reaction. Her arm swelled up, the swelling went all the way up to her ear and into her hair. She had been taking Benadryl, Zyrtec, and using different lotions to treat it. The patient''s arm was sore as well. The caller said that his wife''s arm had improved from what it was like on 10 Sep 2021. Stated it was really raised back then, and about 4 inches long. Also had dots, bumps, welts, on her chest, neck, abdomen, arms, armpits, down in the groin area, and her buttocks, Aspercreme with Lidocaine as well. Overall, the welts had settled. Still had a red, solid, raised area around her neck. Caller stated that he called Urgent Care over the weekend and asked if they had Epinephrine. Stated he didn''t think about it before he called them; but his wife wasn''t having anaphylaxis, she was breathing okay, and her pulse was okay. Stated her symptoms were not life-threatening. Caller mentions that his wife''s ears itch. Urgent Care told the caller that he would have to take his wife to the Emergency Room if they needed Epinephrine. Caller stated that his wife went to her doctor yesterday, and her symptoms had settled down considerably. Her doctor told them to continue what they had been doing with the Benadryl, Zyrtec, baths; the doctor said if it did not go away, they may look at treatment with Steroids. Caller stated that all his wife''s symptoms are improving, but not completely gone. They started on 09Sep2021. They were the worst on the 10 and 11Sep2021. The events resulted in visit to Physician Office. The patient underwent lab tests and procedures which included heart rate: 70 on an unspecified date, heart rate: okay, her pulse is okay on an unspecified date. Therapeutic measures were taken as a result of, had dots, bumps, welts, on her chest, neck, abdomen, arms, armpits, down in the groin area, and her buttocks (urticaria). The clinical outcome of the events was recovering at the time of report. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101215198 same reporter/patient/product, different dose/event.


VAERS ID: 1767425 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301307A / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Goitre, Musculoskeletal stiffness, Myalgia, Off label use, Product use issue, Thyroid disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease (verbatim:Hashimoto''s From autoimmune)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101240948

Write-up: Chest pains; Thyroid throbbing; Thyroid swelling; Muscle pains; Muscle stiffness; BNT162B2 and Influenza vaccine given on 09Sep2021; BNT162B2 and Influenza vaccine given on 09Sep2021; This is a spontaneous report from a contactable consumer (patient). This is the first of the two reports. A 38-year-old male patient (age at vaccination: 38-year-old) received bnt162b2 (BNT162B2 also reported as Covid-19 vaccine brand Pfizer, lot 301307A), via an unspecified route of administration in left arm on 09Sep2021 12:00 as dose 2, single for Covid-19 immunisation; influenza vaccine (lot unknown), via an unspecified route of administration in right arm on 09Sep2021 as dose 2, single for immunisation. Medical history included Hashimoto''s autoimmune. Concomitant medication included INFLUENZA VACCINE on 19Aug2021 for immunisation. The patient previously took AUGMENTIN [amoxicillin sodium;clavulanate potassium] and had drug allergy. The patient experienced chest pains, thyroid throbbing, thyroid swelling , muscle pains and muscle stiffness all on 10Sep2021 09:00. Events resulted in Emergency room and clinic visits. He had treatment of steroid, anti inflammatory drugs administered IV. The outcome of events was not recovered.


VAERS ID: 1767537 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling hot, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADIOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Dust allergy; Grass allergy; Hodgkin''s lymphoma; Mite allergy; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101259976

Write-up: Broke out in hives on back, but, arms and legs; Where the hives were skin itched and felt hot to touch; Where the hives were skin itched and felt hot to touch; This is a spontaneous report from a non contactable consumer reported for herself. A 47-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Sep2021 (Batch/Lot Number: FC3183) at the age of 47 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hodgkin''s disease, grass allergy, pollen allergy, dust allergy, mite allergy, allergy to animal. Concomitant medication included estradiol (ESTRADIOL). Historical Vaccine included BNT162B2 administered on 19Aug2021 at the age of 47 years, dose 1 (Batch/lot number: FA6780) Anatomical Location: Arm left Reported Event: felt sick, tired, and extreme headache about 12 hours after shot lasted 24 hours. On 09Sep2021 patient broke out in hives on back, but, arms and legs 4 hours after dose hives would go away and come back for 8 days where the hives were skin itched and felt hot to touch. Outcome of events is recovering. Therapeutic measures were taken: Benadryl.Prior to vaccination, was the patient diagnosed with COVID-19: No. nce the vaccination, has the patient been tested for COVID-19: No No follow-up attempts are possible. No further information is expected; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101259965 as same reporter/patient/drug, different dose/event


VAERS ID: 1767760 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was provided. No treatment medication details was provided. The vaccine was administered after 15 days of first puncture. This case was linked to MOD-2021-333740 (Patient Link).


VAERS ID: 1768015 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypersensitivity, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexoprol 10 mg
Current Illness: Von Willebrand, Major Depressive Disorder and Anxiety
Preexisting Conditions: Von Willebrand, Major Depressive Disorder and Anxiety
Allergies: No known allergies
Diagnostic Lab Data: None taken after time of event.
CDC Split Type:

Write-up: I took first dose of COVID- 19 (Pfizer) September 9, 2021 @ 3:30pm. Around 4:00pm to 4:30pm I started having an allergic reaction. With-in a hour span I started itching on my thighs, arms, chest, back, face, ears and eyes. I called the health care professional that gave me the vaccination and explained that I was severely itching. She advised me to go back to clinic and get a steroid injection to stop the allergic reaction. I got the steroid injection around 5:10pm. My symptoms started to slowly stop after getting the steroid injection but it took a couple of hours for all the itching to completely stop. On October 4, 2021 around 3:45pm I went to my doctors appointment with my primary care physician and explained that I had an allergic reaction to the first vaccination and he advised me to report this occurs to the CDC.


VAERS ID: 1768329 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Pain, Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: proair inhaler, coenzyme q10, zinc, ascorbic acid, cholecalciferol, magnesium, multivitamin, tocopherol, glucosamine
Current Illness:
Preexisting Conditions: malignant neoplasm of prostate, hernia, obesity
Allergies: penicillin, sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: rash that started on lower legs initially and eventually had head to toe rash/hives that lasted for a week. aches, headache, chills, and a fever that lasted several days. Highest temp 100.9.


VAERS ID: 1768341 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-27
Onset:2021-09-09
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Acne, Amenorrhoea, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Melatonin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: My child missed her menstrual period. She received her 2nd dose of Pfizer Covid-19 vaccination on 8/27/2021. She was expected to start her period on 9/9/21 and did not. I took her to the doctor on 9/20/21. The doctor was unsure why she didn''t have a period. She also started her on birth control to help with heavy periods and acne.


VAERS ID: 1768810 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heart rate increased, Mouth ulceration, Night sweats, Palpitations, Swelling face
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Spironolactone 50 mg/ 1 per day
Current Illness: None
Preexisting Conditions: Mitro Valve Prolapse
Allergies: Percocet, Codeine, Vicodin, Tramadol
Diagnostic Lab Data: ENT Dr stated the facial swelling may possibly be from the Juvaderm facial filler on the right side of my face. He is not 100% sure. As of today 10/7/21 I still have facial swelling. Family Dr. gave me prednisone topical for my oral ulcers. 9/15/21 As of today 10/7/21 I still have oral mouth ulcers.
CDC Split Type:

Write-up: 4 hours after injection, rapid heart rate, cardiac palpitations (subsided) 2 days later severe night sweats (after 4 weeks still having severe night sweats) 6 days later, oral mouth ulcers, facial swelling (after 4 weeks still have oral ulcers, facial swelling (has gone down but still evident))


VAERS ID: 1768956 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Electrocardiogram normal, Laboratory test normal, Limb discomfort
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: Sulfa
Diagnostic Lab Data: Went to urgent care and EKG and labs normal. Seen in primary care office chest discomfort still present, with SOB elevated blood pressure and left arm discomfort Started on ACE and prednisone and has slowly improved
CDC Split Type:

Write-up: The day after the vaccine she started having chest discomfort, feels like a pressure that will not go away. She also noticed that her blood pressure has been elevated.


VAERS ID: 1768975 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-09-02
Onset:2021-09-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA D58E21A / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Extra dose administered
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Alopurinol, Testosterone 200mg bi weekly shots
Current Illness: I was treated for Lyme Disease one month before
Preexisting Conditions: gout kept in check with medicine. Otherwise very good. This spring a major insurance company did full work up and determined I was in very good shape.
Allergies: egg whites
Diagnostic Lab Data: I had physical last week. Doctor recommended Olmesartan Medoxomil H. My blood pressure is still 90 over 180 after taking medicine.
CDC Split Type:

Write-up: My blood pressure has been 80 over 120 range for years (all my life). It want up to 90 over 145 after second shot (March 2021). I was bitten by tick in August (with bite mark) and was treated within a week. I was told it compromises immune systems so I got third Moderna shot. My blood pressure is consistently 90 over 180 to 200.


VAERS ID: 1770024 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Nodule, Pain in extremity, Paraesthesia, Peripheral swelling, Vision blurred, X-ray
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Estradiol Citalopram Adderall Bupropion
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: ER/xray
CDC Split Type:

Write-up: Tingly hands and fingers all day and night. right leg swells, aches and formed a big Knot. Blurry vision, saw double for a few days. I had less symptoms when I had covid. This is crazy. Not a one size fits all shot!


VAERS ID: 1771114 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-28
Onset:2021-09-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Fall, Headache
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORENITRAM; TREPROSTINIL
Current Illness: Pulmonary arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Computerised tomogram; Result Unstructured Data: did not break anything
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Headache; Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension and TREPROSTINIL for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. On 28-Jul-2021, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 mg every eight hours and TREPROSTINIL (Oral) dosage was changed to 2 mg every eight hours. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 mg every eight hours On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 mg every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2 mg every eight hours and TREPROSTINIL (Oral) 2.5 mg every eight hours. and TREPROSTINIL (Oral) dosage was changed to 3 mg every eight hours. On 09-Sep-2021, the patient experienced FALL (Fall). On an unknown date, the patient experienced HEADACHE (Headache). In September 2021, FALL (Fall) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Computerised tomogram: normal (normal) did not break anything. No treatment information was provided. No concomitant medication was provided


VAERS ID: 1771425 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-09-09
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Headache, Nausea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 9/13/2021 - PCR test - positive result
CDC Split Type: vsafe

Write-up: Horrible headache that lasted several days that wouldn''t go away - worst in my life. Nausea - I wanted to throw up. That was for a few days and I had a slight cough, too. I do still have a lingering deep cough. I used Advil or Tylenol for headache; drank water; taking zinc and Vit C.


VAERS ID: 1771540 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Breast pain, Lymph node pain, Lymphadenopathy, Neck pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Lipodystrophy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 102.1; lymph node swelling with pain on left side under arm, breast, neck. Fever lasted for 2 days, swelling for at least 5 days. Still note a ''lump'' in left arm pit / side breast area. Called provider''s office next day after shot but no one returned call.


VAERS ID: 1771685 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Ultrasound scan, Uterine spasm, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WELLBUTRIN XL
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Ultrasound
CDC Split Type: vsafe

Write-up: The day after the vaccine 9/8/2021, I started having uterine cramping and spotting. This lasted 18 days. I then went into having my period. It was worse and heavier than normal. It also lasted longer than usual. I went to my GYN who recommended an ultrasound. I did that yesterday 10/7/2021 and am awaiting results.


VAERS ID: 1771699 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: none - the employee has reported no issues or concerns
CDC Split Type:

Write-up: Patient''s first 2 Covid vaccines were Pfizer. His first Pfizer shot was 12/24/2020. His second Pfizer shot was 01/14/2021. I did not have his vaccine card in front of me when I administered the 3rd Covid vaccine. His 3rd vaccine was administered on 09/09/2021. He was administered Moderna. All literature states what you start with is what you should stick with. He has reported no issues or concerns. Main campus noticed the error and brought it to my attention which is why I am just now reporting.


VAERS ID: 1771705 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: no issues or concerns brought to my attention by the employee
CDC Split Type:

Write-up: Patient''s first 2 Covid vaccines were Pfizer. Her first Pfizer shot was 12/18/2020. Her second Pfizer shot was 01/08/2021. I did not have her vaccine card in front of me when I administered the 3rd Covid vaccine. Her 3rd vaccine was administered on 09/09/2021. She was administered Moderna. All literature states what you start with is what you should stick with. She has reported no issues or concerns. Main campus noticed the error and brought it to my attention which is why I am just now reporting.


VAERS ID: 1771838 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-01-18
Onset:2021-09-09
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Body temperature increased, COVID-19, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Positive Covid-19 test of unknown type.
CDC Split Type:

Write-up: C/O elevated temperature and loss of taste/smell


VAERS ID: 1772000 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / UNK - / IM

Administered by: Military       Purchased by: ?
Symptoms: Condition aggravated, Dysphagia, Nasal pruritus, Rhinitis allergic, Rhinorrhoea, Sneezing, Swelling face, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: allergic rhinitis, GERD
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: 7Oct21 30 y/o male referred for history of adverse event following Pfizer COVID-19 vaccination on 8Sep21 with Pfizer vaccination. The member reports that received the Pfizer COVID 19 vaccine at the MTF and within 8 minutes noticed profuse nasal drainage, notified the RN who brought to a treatment area for observation and observed then within a few minutes throat became extremely itchy and felt like was hard to swallow, not necessarily hard to breathe. Was administered epi pen and EMS called to transport him to the ED. Gave him steroids and discharged home. Did not have any rash or itching outside of the throat. In the morning after the vaccination, when woke felt better but had sneezing, itchy nose, itchy throat, nasal drainage, and in the afternoon morning noted had puffiness in his face which lasted for 24 hours. Then had a flare of what seemed like typical allergy symptoms for him (in terms of allergic rhinitis) e allergy symptoms ever for about a week (has established severe seasonal allergies). No history of any type of reaction to other medications, vaccines or foods.


VAERS ID: 1772150 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Discomfort, Pruritus, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After receiving the 1st dose of the Pfizer Vaccine I developed an itching rash that lasted two weeks and spread all over my body. It started on my shoulders, neck, and upper chest area, and soon covered my entire back. It then spread to my stomach, arms, upper legs, and eventually my feet. I used Cortizone-10, Tylenol, & Showers to relieve the itching & reported the incident to my Doctor''s office. The Doctor advised to continue with Cortisone and use zyrtec or benadryl if needed. It was an extremely uncomfortable two weeks, and not knowing the extent of what was happening was concerning. Daily Log describing the daily progression of the full body rash experienced after the Pfizer Covid19 Vaccine: Wed 9/8/21 11:40am Received Pfizer Covid Vaccine Thu 9/9 noticed slight itch on shoulders by end of day Fri 9/10 noticeable rash on shoulders by end of day Fri. Started treating daily with Cortisone-10, Tylenol, Showers, to relieve itching & discomfort Sat 9/11 itchy rash on entire back, chest & neck Sun 9/12 itchy rash on entire back, chest & neck worsening Mon 9/13 itchy rash on entire back, chest & neck worsening Reported the symptoms to the Dr''s Office Tue 9/14 itchy rash on entire back, chest & neck Wed 9/15 itchy rash on entire back, chest & neck spreading to arms, stomach, upper legs Thu 9/16 slight fade on shoulders & upper back, itching upper legs & arms Fri 9/17 still spreading on upper legs & arms Sat 9/18 Arms and back itching, still spreading to thighs, upper legs, feet. Slight fade on back & upper chest. Sun 9/19 fading on back, chest & upper arms, but still itching. Forearms & upper legs, thighs, itching. Mon 9/20 Back, chest, stomach, upper arms fading. Forearms, upper legs fading but still itch. Rash spread to feet, but not noticeable on shins or ankles.. Tue 9/21 Rash fading, slight itch on forearms, No Cortisone-10 today Wed 9/22 Rash present but fading on thighs Thu 9/23 Mostly faded. Fri 9/24 Mostly faded.


VAERS ID: 1773148 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-09-02
Onset:2021-09-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes zoster, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATACAND; TRILIPIX; PLAQUENIL; Folic acid; WELLBUTRIN; LOVAZA.
Current Illness:
Preexisting Conditions: Rheumatoid arthritis; HBP; Hyperlipidemia
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: The day of Sept 9, an itching began in the belly from the navel to the left side. The itch was all the time and not controlled. It formed a few hives. I went to the doctor Sept 15 and was diagnosed with Shingles. They medicated me with ZOVIRAX 800mg for 7 days.


VAERS ID: 1775549 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-24
Onset:2021-09-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Affective disorder, Apathy, Depression, Intermenstrual bleeding, Libido decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: probiotic melatonin, l-theanine, magnesium (brand Natural Calm, for sleep aid)
Current Illness: none
Preexisting Conditions: none
Allergies: ciprofloxin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: About two weeks after being vaccinated I starting having, and continue to have, frequent menstrual spotting. My mood has been adversely affected. I am depressed, with no motivation and diminished sex drive. This is very unlike me and has negatively impacted my mental health and relationship with my husband.


VAERS ID: 1775942 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-04
Onset:2021-09-09
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Erythema, Feeling hot, Flushing, Hypersensitivity, Mobility decreased, Musculoskeletal stiffness, Paraesthesia, Pyrexia, Rash, Skin tightness, Taste disorder, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrhythmia; Bee sting; Drug allergy (synthetic vit a); Drug allergy (Sulfar drug and pen v k); Drug allergy (breakthrough idonine contrast); Hives; Labile blood pressure; Tinnitus; Urticaria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Vaccination site swelling; Hot to the touch right arm from elbow to shoulder; Could not lift right arm; Felt tightness in right arm; Vaccination site pain; Vaccination site pruritus; Unusual taste; tingling; flushing; with the skin being tight; it started to get real hot and red; rash; Vaccination site itching; vaccination site redness; vaccination site rash; chills; I started to feel soreness at the site then my arm was hurting me so; with swelling in mid arm area between injection site and elbow; It was itchy and feverish; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), FEELING HOT (Hot to the touch right arm from elbow to shoulder), MOBILITY DECREASED (Could not lift right arm), MUSCULOSKELETAL STIFFNESS (Felt tightness in right arm) and VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting, Hives, Urticaria, Drug allergy (Sulfar drug and pen v k), Drug allergy (synthetic vit a), Drug allergy (breakthrough idonine contrast), Labile blood pressure, Arrhythmia and Tinnitus. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), FEELING HOT (Hot to the touch right arm from elbow to shoulder), MOBILITY DECREASED (Could not lift right arm), MUSCULOSKELETAL STIFFNESS (Felt tightness in right arm), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus), TASTE DISORDER (Unusual taste), PARAESTHESIA (tingling), FLUSHING (flushing), SKIN TIGHTNESS (with the skin being tight), ERYTHEMA (it started to get real hot and red), RASH (rash), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE ERYTHEMA (vaccination site redness), VACCINATION SITE RASH (vaccination site rash), CHILLS (chills), VACCINATION SITE PAIN (I started to feel soreness at the site then my arm was hurting me so), VACCINATION SITE SWELLING (with swelling in mid arm area between injection site and elbow), PYREXIA (It was itchy and feverish) and HYPERSENSITIVITY (Hypersensitivity reaction). On 13-Sep-2021, TASTE DISORDER (Unusual taste), PARAESTHESIA (tingling), FLUSHING (flushing), VACCINATION SITE PRURITUS (Vaccination site itching), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site rash) had not resolved, CHILLS (chills) and PYREXIA (It was itchy and feverish) had resolved. On 20-Sep-2021, VACCINATION SITE SWELLING (Vaccination site swelling), FEELING HOT (Hot to the touch right arm from elbow to shoulder), MOBILITY DECREASED (Could not lift right arm) and MUSCULOSKELETAL STIFFNESS (Felt tightness in right arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus), SKIN TIGHTNESS (with the skin being tight), ERYTHEMA (it started to get real hot and red), RASH (rash), VACCINATION SITE PAIN (I started to feel soreness at the site then my arm was hurting me so), VACCINATION SITE SWELLING (with swelling in mid arm area between injection site and elbow) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medicine were reported by the reporter Treatment: Medications included Cold press Patient is having lot of cytotoxins in her body Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up appended Included Reporter Information, Medical history & Events updated


VAERS ID: 1776046 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009C21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Administered after possible temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Oct-2021 and was forwarded to Moderna on 01-Oct-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Administered after possible temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Administered after possible temperature excursion). On 09-Sep-2021, PRODUCT STORAGE ERROR (Administered after possible temperature excursion) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported.


VAERS ID: 1776930 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 05Z1E21A / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Bicytopenia, Cardiac failure congestive, Chills, Condition aggravated, Encephalopathy, Mental status changes, Pyrexia, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Coreg, Lasix, Digoxin, Isosorbide monohydrate, simvastatin, pradaxa, Linzess, vitamin d complex-folic acid
Current Illness: Constipation
Preexisting Conditions: ischemic cardiomyopathy, CAD, compensated CHF, venous stasis edema, vitamin d deficiency, hyperlipidemia, paroxysmal afib
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: 09/09/21 - encephalopathy (admitted to hospital and d/c on 9/10) 09/10/21 - rigors, chills, fever, altered mental status (admitted) 09/12/21 - hypoxic respiratory failure (received Lasix) and bicytopenia noted, systolic CHF with exacerbation due to IV fluids (IV Lasix given)


VAERS ID: 1777016 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-10
Onset:2021-09-09
   Days after vaccination:211
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 01320A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: case was asymptomatic, tested because of exposure


VAERS ID: 1777974 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Erythema, Induration, Pain in extremity, Peripheral swelling, Superficial vein thrombosis, Ultrasound scan abnormal, Vascular pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 5 mg of Tadalafil
Current Illness: None
Preexisting Conditions: Fatigue
Allergies: None
Diagnostic Lab Data: ultrasound & bloodwork on 9/16
CDC Split Type:

Write-up: On September 7, 2021, I received my J &J Covid-19 shot in my left arm. Around September 9th, 2021, the inside of my left arm began to swell, was rosy red in color and was painful to the touch. The vein along the inside of my left arm was hard extending from the middle bicep to the break in my arm. Around September 13th or 14th, the vein in my left arm continued to be hard and the hardness began to extend to my left forearm. On September 16th, 2021, the physical symptoms and pain in the vein were still present and I went to the Hospital ER. During that visit, an ultrasound was conducted, reviewed by the ER doctor and PA. I was diagnosed with Superficial Thrombophlebitis.


VAERS ID: 1779101 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Attention deficit hyperactivity disorder, Balance disorder, Confusional state, Depression, Fatigue, Feeling abnormal, Pyrexia, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxybutynin, Pravastatin, Doxycycline
Current Illness: Side effects at 1st Pfizer dose on 7/31/21
Preexisting Conditions: Rosacea, bladder incontinence, high cholesterol
Allergies: Keflex, betadine tincture
Diagnostic Lab Data: Self reported to physician on 9/24/21
CDC Split Type:

Write-up: Loss of balance, sensory deficits, fuzzy thinking, confusion, ADHD behavior, depression, fever, fatigue


VAERS ID: 1779487 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-08
Onset:2021-09-09
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / UNK RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID 19


VAERS ID: 1779662 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Encephalopathy, Hypoaesthesia, Impaired work ability, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt healthy 38 year old female s/p moderna covid-19 immunization 9/8/21 developed numbness/tingling bilateral hands and arms and encephalopathic brain changes- unable to calculate or do her daily accounting job.


VAERS ID: 1780111 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-03
Onset:2021-09-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 062E21A / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthritis, Arthritis reactive, C-reactive protein, Polyarthritis, Red blood cell sedimentation rate, Rheumatoid factor negative, Serology negative, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Conjunctival disorders (narrow), Ocular infections (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Perindopril, amlodipine, lipitor, famotidine
Current Illness:
Preexisting Conditions: Hypertension
Allergies: Allergic to iodine contrast
Diagnostic Lab Data: Elevated white blood cell count, C-reactive protein, and ESR. Negative serologies for lupus, rheumatoid arthritis, gout, and Lyme disease.
CDC Split Type:

Write-up: Reactive arthritis, starting with acute monoarticular arthritis of the right knee, then progressing to a migratory polyarthritis, with involvement of both knees, both wrists, both thumbs, jaw, and PIP joints of the left hand


VAERS ID: 1780790 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-02
Onset:2021-09-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037F21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstrual disorder, Oligomenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: First menstrual cycle after second dose lasted 4 days longer than normal and I experienced far worse cramps than normal. Additionally I have experienced spotting and bleeding between that menstrual cycle (16 Sept-22 september) 2021) and now. (13 october 2021) My next menstrual cycle is due to start in 3 days. My period is managed by nuva ring and I have never experienced these symptoms while on this form of birth control which I have been taking for approximately 1 year.


VAERS ID: 1782310 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-09
Onset:2021-09-09
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW00217 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstrual disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: My last mentrual cycle was prior to receiving the vaccine and I am always regular. Nothing else in my life had changed. I have missed 2 consecutive cycles and will be contacting my doctor if I miss 1 more. There is no reason for my cycle to have just stopped, I have not changed anything to cause this.


VAERS ID: 1782398 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Chills, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Dizziness, Fall, Feeling abnormal, Grip strength decreased, Headache, Hyperhidrosis, Hypoaesthesia, Injection site pain, Movement disorder, Muscular weakness, Musculoskeletal stiffness, Pain, Pain in extremity, Paraesthesia, Pyrexia, Sinus congestion, Tremor, Visual impairment, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propranolol 80mg four times daily Estradiol10mcg insert 2x week Pantoprazole 40mg daily AM Famotidine 40mg daily PM Calcium Carbonate 500mg, twice a day Vitamin D3 1000iu daily Zinc 10mg daily Krill oil 1000mg daily B-Complex time releas
Current Illness: autoimmune, CIDP
Preexisting Conditions: autoimmune, CIDP
Allergies: tinidazole
Diagnostic Lab Data:
CDC Split Type:

Write-up: stiff neck, headache, closed sinuses, injection site pain, fever, body aches, chills, sweats. Fever as high as 102 CIDP Neuromuscular symptoms WAY WORSE with 2nd shot. Hands very numb and tingling Hand tremors exaggerated. Pinky fingers keep pulling away. No grip, no movement control. Balance WAY WORSE. Leg muscle trembling & weakness, collapsing. Had to use walker CAUTIOUSLY. Burning painful feet and legs. Dizzy and odd head feelings. Eyesight weird, like it was faded.


VAERS ID: 1782456 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-16
Onset:2021-09-09
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006821A / UNK - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID 19


VAERS ID: 1782480 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-18
Onset:2021-09-09
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID 19


VAERS ID: 1782488 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-02
Onset:2021-09-09
   Days after vaccination:219
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD, Hypertension, History of Breast Cancer, History of Head and Neck cancer with tongue resection, Hyperlipidemia, Chronic anemia, Anxiety, DVT
Allergies: Doxycycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: Admission to critical care hospital with COVID-19 diagnosis on admission


VAERS ID: 1782531 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-09-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID 19


VAERS ID: 1782815 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 1 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Not recommended for age


VAERS ID: 1782825 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 1 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Not recommended for age


VAERS ID: 1782831 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 1 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Age not recommended for vaccine


VAERS ID: 1782832 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA; STAFF HAVE BEEN RETRAINED ON PROPER ADMINISTRATION OF VACCINE; ATTEMPTING TO SCHEDULE PATIENT FOR RE-VACCINATION


VAERS ID: 1782843 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA; STAFF HAVE BEEN RETRAINED ON PROPER ADMINISTRATION OF VACCINE; ATTEMPTING TO SCHEDULE PATIENT FOR RE-VACCINATION


VAERS ID: 1782851 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Immunisation, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA VACCINE; PATIENT WAS RE-VACCINATED ON 10/7 AND STAFF WERE TRAINED ON PROPER DOSING AND ADMINISTRATION.


VAERS ID: 1782859 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Immunisation, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA VACCINE; PATIENT WAS RE-VACCINATED ON 10/7 AND STAFF WERE TRAINED ON PROPER DOSING AND ADMINISTRATION.


VAERS ID: 1782863 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT WAS GIVEN PARTIAL DOSE OF MODERNA VACCINE; PATIENT WAS RE-VACCINATED ON 10/7 AND STAFF WERE TRAINED ON PROPER DOSING AND ADMINISTRATION.


VAERS ID: 1783622 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Antinuclear antibody positive, Balance disorder, CSF immunoglobulin increased, CSF oligoclonal band absent, CSF protein normal, Computerised tomogram head, Diplopia, Disorientation, Dizziness, Gait disturbance, Hyperintensity in brain deep nuclei, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Nystagmus, Pain, Pleocytosis, Pupils unequal, Relapsing-remitting multiple sclerosis, Visual impairment
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluoxetine 40mg daily, Prazosin 5mg nightly, Symbicort 80/4.5 2 puffs BID and Xyzal 5mg BID
Current Illness: No new or worsening conditions.
Preexisting Conditions: Allergic rhinitis, intermittent asthma, idiopathic urticaria, depression/anxiety
Allergies: Eggs and what per allergy testing, though she consumes these without reaction
Diagnostic Lab Data: Head CT 9/20/21, MRI brain 9/20/21, MRI cervical and thoracic spine 9/21/21
CDC Split Type:

Write-up: She had her first Moderna COVID vaccine 9/7/21. She felt a little achy for the next 24 hours afterwards. 9/9/21 she got home from work, was up on the deck, looked out "and I just felt a little disoriented, my vision was delayed a little." She drove herself to volleyball, played with some difficulty due to her vision. The next day her vision got worse - "I don''t even know how to describe it, I wasn''t dizzy necessarily but that was the closest thing I could come up with." She worked that day. 9/11/21 (Saturday) she woke up "and I couldn''t walk well, I was super off balance, I needed help walking." She noticed her pupils were different sizes for a few hours that day. She didn''t go to work that night. Sunday 9/12/21 her girlfriend noticed some nystagmus when she was looking to the left. By Monday 9/20/21 she had up and down double vision and went to the ER. MRI head revealed multiple areas of FLAIR hyperintensity oriented perpendicular to the ventricles and an enhancing area of FLAIR hyperintensity in the body of the corpus callosum. CSF studies notable for mild lymphocytic pleocytosis with normal protein and positive oligoclonal banding with elevated IgG and IgG index concerning for MS. She was treated with 1mg methylprednisone for 5 days (9/21-9/25) with mild improvement of diplopia and gait instability. She saw a neuromuscular specialist at a local HCF 9/27/21 who diagnosed her with relapsing remitting MS. The only neurologic episode Pt recalls previous to this was an episode of vertigo for about 1 week a few years ago that was mild and resolved on its own. Per Dr.''s report Pt has been having idiopathic hives on and off for about a year, did see an allergist and a rheumatologist who found her to have a mildly positive ANA with a titer of 1:80, nucleolar pattern.


VAERS ID: 1784848 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-01-19
Onset:2021-09-09
   Days after vaccination:233
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19 pneumonia, Dyspnoea, Fatigue, Gait inability, Malaise, Productive cough, Sputum discoloured
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: HISTORY OF PRESENT ILLNESS: This 83-year-old male with a past medical history of coronary artery disease, a history of CVA with residual right-sided weakness, iron-deficiency anemia comes in for complaint of ongoing shortness of breath and worsening malaise, fatigue, weakness. Patient stated that, over the past 3 days, he has begun to experience symptoms of increasing progressive shortness of breath where he was unable to ambulate. He also stated that he was coughing with dark brown sputum. He is admitted for coronavirus 2019 pneumonitis.


VAERS ID: 1785316 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-05-10
Onset:2021-09-09
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Symptoms began: 9/3/2021. Patient was hospitalized due to COVID. Patient is fully vaccinated.


VAERS ID: 1785336 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-20
Onset:2021-09-09
   Days after vaccination:201
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030M20A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, General physical health deterioration, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic Renal Disease, Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PUI was admitted to Hospital from 9/9/2021 to 9/12/2021. He was just brought home from the hospital last night by ambulance. He was taken to the ER this AM by ambulance again. She is not sure if he will be admitted or released home. She provided info on his previous hosp stay (below.) PUI first tested positive 2 weeks before his hospital admit but his status worsened over those 2 wks. UI was admitted again to Hospital from 9/13/2021 t0 9/17/2021. He was not in the ICU during that 2nd stay, and did not need the ventilator. He had 2 separate hospital admissions during this COVID illness, and was fully vaccinated.


VAERS ID: 1785576 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN TRANSCRIBED / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Haematochezia, Headache, Pruritus
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FAMOTIDINE, PREDNISONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: allergy to CECLOR
Diagnostic Lab Data: no medical tests complete
CDC Split Type:

Write-up: pt experienced itchiness, shortness of breath, headaches, blood in stool. pt was seen a local ER out in town. pt was given prednisone and famotidine.


VAERS ID: 1785697 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known of
Current Illness: CKD, Vertigo. AAA, Hearing loss,
Preexisting Conditions: See Other illnesses above
Allergies: PCN ASA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt remained in clinic for 30 min. Pt had his 2 Moderna vaccines in the past. Was given a Pfizer Booster by mistake. No adverse reaction that this nurse knows of.


VAERS ID: 1785735 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-04-07
Onset:2021-09-09
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Endometritis, Exposure during pregnancy, Mastitis, Uterine inversion
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Functional lactation disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamins
Current Illness: none
Preexisting Conditions: none
Allergies: Azithromycin
Diagnostic Lab Data: none
CDC Split Type: vsafe

Write-up: I had the delivery of my first child. During the delivery I was fine at first, but then I experienced an uterine inversion. I had to have an emergency surgery. My baby was 7 lbs. 14 oz. During the pregnancy I had no complications. I was prescribed pain killers after the surgery. I also had a mastitis and endometriosis infection. I was prescribed antibiotics for that.


VAERS ID: 1785762 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-23
Onset:2021-09-09
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Biopsy skin abnormal, Blood test, Chest X-ray, Dyspnoea, Echocardiogram, Electrocardiogram, Henoch-Schonlein purpura, Rash, Renal disorder, Urine analysis, Weight increased
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BABY.ASPIRIN PM TURMERIC CURCUMIN 1200 MG AM NATURES BOUNTY (PROBIOTIC) AM CENTRA SILVER AM COQ10 300MG PM - - - - - - - - - - - - - - - - - - - - - ALTACE
Current Illness:
Preexisting Conditions: diabetes
Allergies:
Diagnostic Lab Data: chest x-ray, blood tests, oxygen level, urinanalysis, EKG, ECO cardiogram (9/10/21) skin biopsy Diagnosis - HSP vasculitis
CDC Split Type:

Write-up: Shortness of breath, weight gain, rash over extremities, major changes in kidney


VAERS ID: 1786348 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram, Immediate post-injection reaction, Pericarditis, Ultrasound scan, X-ray
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Several EKGs, blood work, X-rays, and an ultra sounds
CDC Split Type:

Write-up: Immediate chest pains and trouble breathing followed by pericarditis in the heart.


VAERS ID: 1686230 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Hyperhidrosis, Migraine, Neck pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline 75mg
Current Illness:
Preexisting Conditions:
Allergies: N/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vomiting, migraine, neck pain, fever and sweats


VAERS ID: 1688845 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Peripheral swelling, Somnolence, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vomiting Weakness Headache Feet sweating Dizziness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache Weakness Vomit only once Dizziness Sweating in the feet Super sleepy


VAERS ID: 1688854 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C16-03 / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bone pain, Dyspnoea, Mobility decreased, Muscle spasms, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: At around 19:30 I developed a bad fever, about an hour later I started to develop muscle cramps, sore bones and could no longer move from the position in my bed. I couldn''t open my eyes and when I took in a breath it felt like I was breathing through a sponge. I called the hospital and they advised me to take a paracetamol which did help however the next day (today) I am still very weak, nauseous and in a lot of muscle pain.


VAERS ID: 1701013 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821288 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive
CDC Split Type: BRJNJFOC20210924947

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 40 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1821288, expiry: unknown) dose was not reported, frequency one total, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. Laboratory data included: COVID-19 RT-PCR (Real-time reverse transcriptase-polymerase chain reaction) test was positive. Patient was fine and had no serious symptoms, just lacking in taste and smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirm covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender''s Comments: V0: 20210924947- COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1703741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Application site pain, Chills, Fatigue, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210928183

Write-up: CHILLS; HEADACHE; APPLICATION SITE PAIN; FATIGUE; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-044184) on 15-SEP-2021 concerned a 38 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE423 expiry: unknown) dose was not reported, 1 total, administered on 08-SEP-2021 for unknown indication. No concomitant medications were reported. On 09-SEP-2021, the patient experienced chills, headache, application site pain and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from application site pain, and the outcome of chills, headache and fatigue was not reported. This report was serious (Other Medically Important Condition).; Reporter''s Comments: That was the strongest effect of a vaccination that I have ever shot. I can''t call it a side effect because the effect is difficult to determine.


VAERS ID: 1707944 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Electrocardiogram, Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ecg hr - 111; Result Unstructured Data: abnormal; Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25919018) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 08-Sep-2021. Concomitant products included PARACETAMOL from 08-Sep-2021 to 09-Sep-2021 for Backache. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. On an unknown date, Electrocardiogram: abnormal (abnormal) abnormal. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After the 24 hour of vaccination patient experienced sob ,chest tightness and fever. Lab data includes ecg hr - 111, short pr, st segment depressions, multiple vpcs. No treatment medications are reported. Company Comment: This case concerns a 19-year-old, female patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event Myocarditis occurred 1 day after the second dose of Spikevax. The rechallenge was unknown, as there was no information regarding the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old, female patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event Myocarditis occurred 1 day after the second dose of Spikevax. The rechallenge was unknown, as there was no information regarding the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1708158 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-09-09
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Pain in extremity, Peripheral swelling, Petit mal epilepsy, Presyncope, Weight, Weight increased
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Swelling of legs
Allergies:
Diagnostic Lab Data: Test Name: Weight; Result Unstructured Data: Weight increased
CDC Split Type: CAMODERNATX, INC.MOD20213

Write-up: ''weight gain all over now so that her clothes are tight; not really fainting but missing a couple of seconds, it''s more like a petit mal seizure; not really fainting but missing a couple of seconds, it''s more like a petit mal seizure; her legs from her knees down were swollen; the pain in the legs was crazy; Huge blood sots on her legs; This spontaneous case was reported by a consumer and describes the occurrence of PETIT MAL EPILEPSY (not really fainting but missing a couple of seconds, it''s more like a petit mal seizure) and HAEMORRHAGE (Huge blood sots on her legs) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Migraine and Swelling of legs. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced HAEMORRHAGE (Huge blood sots on her legs) (seriousness criterion medically significant). On an unknown date, the patient experienced PETIT MAL EPILEPSY (not really fainting but missing a couple of seconds, it''s more like a petit mal seizure) (seriousness criterion medically significant), PRESYNCOPE (not really fainting but missing a couple of seconds, it''s more like a petit mal seizure), PERIPHERAL SWELLING (her legs from her knees down were swollen), PAIN IN EXTREMITY (the pain in the legs was crazy) and WEIGHT INCREASED (''weight gain all over now so that her clothes are tight). At the time of the report, PETIT MAL EPILEPSY (not really fainting but missing a couple of seconds, it''s more like a petit mal seizure), PRESYNCOPE (not really fainting but missing a couple of seconds, it''s more like a petit mal seizure), PERIPHERAL SWELLING (her legs from her knees down were swollen), PAIN IN EXTREMITY (the pain in the legs was crazy), WEIGHT INCREASED (''weight gain all over now so that her clothes are tight) and HAEMORRHAGE (Huge blood sots on her legs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) Weight increased. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. The patient has not had the second dose. The exact same thing happened when she was pregnant 40 years ago. In the past she had experienced swelling of legs, blood spots on her legs and weight gain. The patient was treated with steroids, antibiotics, & something for fluid retention in the past (and not at present for the reported events). Company comment: This report concerns a 65 year old female patient who developed unexpected non-serious events of peripheral swelling, pain in extremity, bleeding spots on her legs, near fainting (pre-syncope) and weight gain unknown duration following vaccination with first dose of mRNA-1273. The patient reports having similar complaints in the past (when she was pregnant). The patient has not yet taken her second dose of the vaccine. Very limited information regarding the events has been provided at this time. The benefit-risk relationship of mRNA is not affected by this report.; Sender''s Comments: This report concerns a 65 year old female patient who developed unexpected non-serious events of peripheral swelling, pain in extremity, bleeding spots on her legs, near fainting (pre-syncope) and weight gain unknown duration following vaccination with first dose of mRNA-1273. The patient reports having similar complaints in the past (when she was pregnant). The patient has not yet taken her second dose of the vaccine. Very limited information regarding the events has been provided at this time. The benefit-risk relationship of mRNA is not affected by this report.


VAERS ID: 1709970 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Chills, Dizziness, Dyspnoea, Headache, Heart rate, Heart rate increased, Muscle fatigue, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to animal (Cat allergy); Allergy to vaccine (Reacted strongly to recommended/free vaccines to travel to Bali in 2019 - temporary loss of sight similar to migraine, and nausea); Drug allergy (Strong Histamine response); Hay fever.
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Nausea.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shortness of breath; mild; resting heart rate after sleep 90; Muscle fatigue; Shivers; Fever; Heart rate; Painful arm; Breath shortness; Armpit pain; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25918184) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (mild), HEART RATE INCREASED (resting heart rate after sleep 90), MUSCLE FATIGUE (Muscle fatigue), CHILLS (Shivers), PYREXIA (Fever), HEART RATE (Heart rate), PAIN IN EXTREMITY (Painful arm), DYSPNOEA (Breath shortness), AXILLARY PAIN (Armpit pain) and HEADACHE (Headache) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. The patient''s past medical history included Migraine and Nausea. Previously administered products included for an unreported indication: HISTAMINE. Concurrent medical conditions included Hay fever, Allergy to animal (Cat allergy), Drug allergy (Strong Histamine response) and Allergy to vaccine (Reacted strongly to recommended/free vaccines to travel to Bali in 2019 - temporary loss of sight similar to migraine, and nausea) since 2019. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEART RATE (Heart rate) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), DYSPNOEA (Breath shortness) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), DIZZINESS (mild) (seriousness criterion medically significant) and HEART RATE INCREASED (resting heart rate after sleep 90) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (shortness of breath), DIZZINESS (mild) and HEART RATE INCREASED (resting heart rate after sleep 90) outcome was unknown, MUSCLE FATIGUE (Muscle fatigue), CHILLS (Shivers), PYREXIA (Fever) and HEART RATE (Heart rate) had not resolved and PAIN IN EXTREMITY (Painful arm), DYSPNOEA (Breath shortness), AXILLARY PAIN (Armpit pain) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was reacted strongly to first dose Moderna COVID-19 Vaccine for 25 minutes feeling flush, and light headed. Patient''s resting heart rate after sleep was 90 and heart rate after walk was 110. Shortness of breath after sleep mild, shortness of breath after walk notable. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial This case concerns a 27-year-old, male patient with no relevant medical history, who experienced the unexpected events of muscle fatigue, chills, pyrexia, heart rate, pain in extremity, dyspnoea, axillary pain, dizziness, heart rater increased and headache. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Sender''s Comments: This case concerns a 27-year-old, male patient with no relevant medical history, who experienced the unexpected events of muscle fatigue, chills, pyrexia, heart rate, pain in extremity, dyspnoea, axillary pain, dizziness, heart rater increased and headache. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1709978 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Knee pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25924149) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a 35-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced ARTHRALGIA (Knee pain) (seriousness criterion disability). At the time of the report, ARTHRALGIA (Knee pain) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No treatment medication were provided No concomitant medication were provided The patient reports that, she was unable to bend knees on both legs, intense pain. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected event of Arthralgia. The event occurred 3 days from onset after the second dose of Spikevax. The rechallenge was unknown as there''s no information about the first dose. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected event of Arthralgia. The event occurred 3 days from onset after the second dose of Spikevax. The rechallenge was unknown as there''s no information about the first dose. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1713176 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Head discomfort, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use; Fear of needles; Non-smoker
Preexisting Conditions: Comments: The patient had history of no known drug allergies, no drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Blood pressure; Result Unstructured Data: 110/80 mmHg
CDC Split Type: ZAJNJFOC20210927131

Write-up: FAINTED; HEAD RUSH; TINGLING IN LEGS; This spontaneous report received from a health care professional concerned a 26 year old male of unspecified ethnic origin. The patient''s weight was 67 kilograms, and height was not reported. The patient''s concurrent conditions included: alcohol use, and non smoker. The patient had history of no known drug allergies, no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported) dose was not reported, 1 total administered on 09-SEP-2021 at left arm for prophylactic vaccination. Vaccine administered by the health care professional at clinic/workplace clinic. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated about an incident that occurred at afternoon from previous day of reporting. On 09-SEP-2021 a patient was fainted 3 minutes post vaccination, while his wife was being vaccinated. The patient stated that he has a absolute fear, and needle phobia, due to repetitive exposure to injections and surgeries when he was younger. On 09-SEP-2021, the patient experienced tingling in legs, head rush. As per the report, It was stated that event (tingling in legs, head rush) were not abated after product stopping or dose reduced. It was also reported that the patient did not experience any harm from the product problem. Laboratory data included: Blood pressure (NR: not provided) 110/80 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head rush, and tingling in legs on 09-SEP-2021, and the outcome of fainted was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210907528, 20210907526, 20210907542, 20210907532 and 20210907949.; Sender''s Comments: V0: 20210927131-covid-19 vaccine ad26.cov2.s-Fainted, Head rush. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210927131-covid-19 vaccine ad26.cov2.s- tingling in legs. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1714583 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea, Chills, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness: Suspected COVID-19 (Unsure when symptoms started.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shivers; fever; Loss of period from the first vaccination (3months missed currently); Vomiting; This case was received (Reference number: GB-MHRA-ADR 25923965) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), PYREXIA (fever), VOMITING (Vomiting) and AMENORRHOEA (Loss of period from the first vaccination (3months missed currently)) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started.). Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) from 2002 to an unknown date for an unknown indication. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and AMENORRHOEA (Loss of period from the first vaccination (3months missed currently)) (seriousness criterion medically significant). On 10-Sep-2021, VOMITING (Vomiting) was resolving. At the time of the report, CHILLS (shivers) and PYREXIA (fever) had not resolved and AMENORRHOEA (Loss of period from the first vaccination (3months missed currently)) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient had experienced temperature, diarrhea. Patient had loss of period from first vaccination( 3 months missed currently). Patient had not tested positive for COVID-19 since having vaccination. Company comment: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the expected events of vomiting, chills and pyrexia. The events occurred approximately 1 day after the second dose of moderna covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not provide in this case. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 29-year-old, female patient with no relevant medical history, who experienced the expected events of vomiting, chills and pyrexia. The events occurred approximately 1 day after the second dose of moderna covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessment was not provide in this case. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1714584 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Chest pain, Dizziness, Dyspepsia, Dyspnoea, Oropharyngeal pain, Palpitations, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Throat pain; Heartburn; Breathing difficult; Chest pain; Weakness; Heart racing; Armpit pain; Fever; Swollen arm; Felt faint; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 25926946) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain), PYREXIA (Fever), OROPHARYNGEAL PAIN (Throat pain), PERIPHERAL SWELLING (Swollen arm), CHEST PAIN (Chest pain), DYSPEPSIA (Heartburn), ASTHENIA (Weakness), PALPITATIONS (Heart racing), DIZZINESS (Felt faint) and DYSPNOEA (Breathing difficult) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 09-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and DIZZINESS (Felt faint) (seriousness criterion medically significant). On 10-Sep-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant) and PALPITATIONS (Heart racing) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain) (seriousness criterion medically significant), DYSPEPSIA (Heartburn) (seriousness criterion medically significant) and DYSPNOEA (Breathing difficult) (seriousness criterion medically significant). At the time of the report, AXILLARY PAIN (Armpit pain), PYREXIA (Fever) and OROPHARYNGEAL PAIN (Throat pain) had not resolved, PERIPHERAL SWELLING (Swollen arm), CHEST PAIN (Chest pain), DYSPEPSIA (Heartburn), ASTHENIA (Weakness) and PALPITATIONS (Heart racing) was resolving and DIZZINESS (Felt faint) and DYSPNOEA (Breathing difficult) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Spikevax) (Unknown Route) and mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient took paracetamol since injection and feel a lot better after but side effects are more severe. 39 hours after the vaccine I had severe sharp pain around ribs, back and next/ throat as well as a high heart rate and breathing difficulties. Patient took paracetamol and felt better after I woke up again. Company Comment: This case concerns a 20-year-old patient of an unknown geneder with no relevant medical history , who experienced the unexpected events of Axillary pain, Pyrexia, Oropharyngeal pain, Peripheral swelling, Chest pain, Dyspepsia, Asthenia, Palpitations, Dizziness and Dyspnoea. The events occurred one day after second dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed . The reporter did not provide any causality assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 20-year-old patient of an unknown geneder with no relevant medical history , who experienced the unexpected events of Axillary pain, Pyrexia, Oropharyngeal pain, Peripheral swelling, Chest pain, Dyspepsia, Asthenia, Palpitations, Dizziness and Dyspnoea. The events occurred one day after second dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed . The reporter did not provide any causality assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1714586 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Photophobia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Stomach pain; Light sensitivity to eye; Light headedness; This case was received via (Reference number: GB-MHRA-ADR 25928245) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PHOTOPHOBIA (Light sensitivity to eye) and DIZZINESS (Light headedness) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 29-Jul-2021 to 10-Aug-2021. Concomitant products included PARACETAMOL from 09-Sep-2021 to an unknown date for Pain. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant) and DIZZINESS (Light headedness) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PHOTOPHOBIA (Light sensitivity to eye) and DIZZINESS (Light headedness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Company Comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of Abdominal pain upper, photophobia and dizziness. The events occurred on the same date after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected events of Abdominal pain upper, photophobia and dizziness. The events occurred on the same date after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1714649 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-09-09
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Limb discomfort, Myalgia, Pain, Pain in extremity, Peripheral coldness, Peripheral swelling, Poor quality sleep, Pruritus, Rash, Skin erosion, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: itchy; shooting pain; difficulty breathing; rash; poor night sleep.; Muscle ache; Raw skin; Cold feet; Cold hands; Shortness of breath; Swollen arm; Skin rash; Skin warm; General body pain; Tight chest; Headache; Sweaty; Painful arm; Heaviness in arm; Inappropriate schedule of vaccine administered; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 25927866) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Swollen arm), RASH (Skin rash), SKIN WARM (Skin warm), PAIN (General body pain), CHEST DISCOMFORT (Tight chest), HEADACHE (Headache), HYPERHIDROSIS (Sweaty), PAIN IN EXTREMITY (Painful arm), LIMB DISCOMFORT (Heaviness in arm), POOR QUALITY SLEEP (poor night sleep.), MYALGIA (Muscle ache), SKIN EROSION (Raw skin), PRURITUS (itchy), PAIN (shooting pain), DYSPNOEA (difficulty breathing), RASH (rash), PERIPHERAL COLDNESS (Cold feet) and PERIPHERAL COLDNESS (Cold hands) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criteria disability and medically significant), LIMB DISCOMFORT (Heaviness in arm) (seriousness criteria disability and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criteria disability and medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criteria disability and medically significant), RASH (Skin rash) (seriousness criteria disability and medically significant), SKIN WARM (Skin warm) (seriousness criteria disability and medically significant), PAIN (General body pain) (seriousness criteria disability and medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant), HYPERHIDROSIS (Sweaty) (seriousness criteria disability and medically significant), MYALGIA (Muscle ache) (seriousness criteria disability and medically significant), SKIN EROSION (Raw skin) (seriousness criteria disability and medically significant), PERIPHERAL COLDNESS (Cold feet) (seriousness criteria disability and medically significant) and PERIPHERAL COLDNESS (Cold hands) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced POOR QUALITY SLEEP (poor night sleep.) (seriousness criteria disability and medically significant), PRURITUS (itchy) (seriousness criteria disability and medically significant), PAIN (shooting pain) (seriousness criteria disability and medically significant), DYSPNOEA (difficulty breathing) (seriousness criteria disability and medically significant) and RASH (rash) (seriousness criteria disability and medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency. On 09-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 11-Sep-2021, PERIPHERAL COLDNESS (Cold feet) and PERIPHERAL COLDNESS (Cold hands) had resolved. At the time of the report, DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Swollen arm), RASH (Skin rash), SKIN WARM (Skin warm), PAIN (General body pain), CHEST DISCOMFORT (Tight chest), HEADACHE (Headache), HYPERHIDROSIS (Sweaty), PAIN IN EXTREMITY (Painful arm) and LIMB DISCOMFORT (Heaviness in arm) had not resolved, POOR QUALITY SLEEP (poor night sleep.) outcome was unknown and MYALGIA (Muscle ache), SKIN EROSION (Raw skin), PRURITUS (itchy), PAIN (shooting pain), DYSPNOEA (difficulty breathing) and RASH (rash) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. On 09-Sep-2021, she experienced arm pain at the site of the injection approximately two hours later, pain got severe as she slept and awoke at 4am on 10-Sep-2021 in tears. Then she developed muscle aches throughout her body and shooting pain randomly throughout her body. Her left arm started to feel heavier and more painful. She developed restricted use of the arm. Her skin become sore to touch all over her body and she experience hot flushes and sweating, along site cold hands and feet. The cold hands and feet subsided after a few hours. Then she developed tightness in my chest along with difficulty breathing deeply. Each breath feels itchy and laboured. she felt tired throughout the day and fell asleep for 3 hours. Her left arm, at the injection site began swelling and discolouring to red. She received unspecified cold and flu tablets containing paracetamol every 4 hours and drank fluids as a treatment. Company Comment: This case concerns a 28-year-old, female patient with no previous relevant medical history, who experienced the unexpected events dyspnoea, peripheral swelling, rash, skim warm, pain, chest discomfort, headache, hyperhidrosis, pain in extremity, limb discomfort, poor quality sleep, myalgia, skin erosion, pruritus and peripheral coldness. The events occurred between 1 and 3 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 28-year-old, female patient with no previous relevant medical history, who experienced the unexpected events dyspnoea, peripheral swelling, rash, skim warm, pain, chest discomfort, headache, hyperhidrosis, pain in extremity, limb discomfort, poor quality sleep, myalgia, skin erosion, pruritus and peripheral coldness. The events occurred between 1 and 3 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events seem to be serious by medical judgement and from a clinical or regulatory standpoint.


VAERS ID: 1716033 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Loss of consciousness, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Passed out; Fever; Headache; Fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25916971) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), SYNCOPE (Fainting), PYREXIA (Fever) and HEADACHE (Headache) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), SYNCOPE (Fainting), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. The day after vaccination, patient passed out during middle of conversation with someone, and then woke up on the floor. Other symptoms included headache (with ringing sound in head after fainting), and fever. No treatment details were provided. Company comment: This case concerns a 23 year-old, male subject with no relevant medical history, who experienced the unexpected events of Syncope, Loss of consciousness, pyrexia and Headache The event occurred approximately 1 day after the second dose of Moderna Covid -19 Vaccine. The event was considered related to the study drug. The benefit-risk relationship of Moderna Covid -19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 23 year-old, male subject with no relevant medical history, who experienced the unexpected events of Syncope, Loss of consciousness, pyrexia and Headache The event occurred approximately 1 day after the second dose of Moderna Covid -19 Vaccine. The event was considered related to the study drug. The benefit-risk relationship of Moderna Covid -19 vaccine is not affected by this report.


VAERS ID: 1716037 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Back pain, Body temperature, Cardiac flutter, Chest pain, Chills, Cough, Dizziness, Nausea, Neck pain, Pyrexia, SARS-CoV-2 test, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: Fever of 40.4; Test Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: weakness; nausea; chills; dizziness; back pain; cough; wheezing; chest pain; Neck pain; heart fluttering; Fever; This case was received via RA (Reference number: -MHRA-ADR 25922234) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NAUSEA (nausea), CHILLS (chills), DIZZINESS (dizziness), BACK PAIN (back pain), COUGH (cough), WHEEZING (wheezing), PYREXIA (Fever) and CARDIAC FLUTTER (heart fluttering) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (weakness) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), BACK PAIN (back pain) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant), WHEEZING (wheezing) (seriousness criterion medically significant), CHEST PAIN (chest pain), NECK PAIN (Neck pain) and CARDIAC FLUTTER (heart fluttering) (seriousness criterion medically significant). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), NAUSEA (nausea), CHILLS (chills), DIZZINESS (dizziness), BACK PAIN (back pain), COUGH (cough), WHEEZING (wheezing), CHEST PAIN (chest pain), NECK PAIN (Neck pain) and CARDIAC FLUTTER (heart fluttering) outcome was unknown and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: 40.4 (Inconclusive) Fever of 40.4. On 10-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use was not provided by the reporter. Patient has not had symptoms associated with COVID-19. Patient is neither pregnant, nor is currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1716038 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Feeling abnormal, Maternal exposure during breast feeding, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: pain; hours; Maternal exposure during breast feeding; shivering; Muscle pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25922543) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), FEELING ABNORMAL (hours), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), CHILLS (shivering) and MYALGIA (Muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), FEELING ABNORMAL (hours) (seriousness criterion medically significant), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, PAIN (pain), FEELING ABNORMAL (hours), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and CHILLS (shivering) outcome was unknown and MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient had shivering about 12 hours after vaccine then severe pain in all muscles after that. Patient had shivering about 12 hours after vaccine then severe pain in all muscles after that. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case refers to a 39-year-old female, breastfeeding patient with no known medical history who experienced the unexpected event of Myalgia on the same day of receiving the first dose of Spikevax and experienced Pain, Feeling Abnormal, Chills and Maternal Exposure During Breastfeeding on an unspecified date. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case refers to a 39-year-old female, breastfeeding patient with no known medical history who experienced the unexpected event of Myalgia on the same day of receiving the first dose of Spikevax and experienced Pain, Feeling Abnormal, Chills and Maternal Exposure During Breastfeeding on an unspecified date. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1716039 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Cluster headache, Fatigue, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: extreme fatigue; Could not leave bed; Muscle ache; Fatigue; Cluster headache; Headache; This case was received via RA (Reference number: 25922876) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), HEADACHE (Headache), MYALGIA (Muscle ache), FATIGUE (Fatigue) and CLUSTER HEADACHE (Cluster headache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and CLUSTER HEADACHE (Cluster headache) (seriousness criterion medically significant). On 10-Sep-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (extreme fatigue) (seriousness criterion medically significant) and BEDRIDDEN (Could not leave bed). At the time of the report, FATIGUE (extreme fatigue) and BEDRIDDEN (Could not leave bed) outcome was unknown and HEADACHE (Headache), MYALGIA (Muscle ache), FATIGUE (Fatigue) and CLUSTER HEADACHE (Cluster headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided No treatment product information was provided SD Narrative: Extreme fatigue, headaches, muscle aches can''t leave bed Company Comment: This case concerns a 38-year-old, male patient with no reported relevant medical history, who experienced the unexpected events of cluster headache, myalgia, extreme fatigue, fatigue, bedridden and headache. The events of headache, cluster headache and fatigue occurred on the same day as second dose of Moderna CoviD-19 Vaccine. The event of Myalgia occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. No onset dates were provided for the events of extreme fatigue or bedridden. The rechallenge was unknown since no information about the first dose was disclosed. No reporter causality was provided. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 38-year-old, male patient with no reported relevant medical history, who experienced the unexpected events of cluster headache, myalgia, extreme fatigue, fatigue, bedridden and headache. The events of headache, cluster headache and fatigue occurred on the same day as second dose of Moderna CoviD-19 Vaccine. The event of Myalgia occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. No onset dates were provided for the events of extreme fatigue or bedridden. The rechallenge was unknown since no information about the first dose was disclosed. No reporter causality was provided. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1716041 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fear, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: fear; Fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25923190) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Fainting) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced FEAR (fear). On 09-Sep-2021, SYNCOPE (Fainting) had resolved. At the time of the report, FEAR (fear) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Patient felt anxious about the vaccination prior to vaccine, after administration fainted and became conscious again before fainting once more. Pharmacist and IA''s helped seat on floor and then in recovery position. PT given water PO (per oral) as well as chocolate due to possible low BMs. Closely observed for around 30 mins and Emergency contact was called. Patient is not enrolled in clinical trial Treatment information was not provided. This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of syncope and fear. The event occurred on the same day after the first dose of mRNA 1273. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of vaccine is not affected by this report.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of syncope and fear. The event occurred on the same day after the first dose of mRNA 1273. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of vaccine is not affected by this report.


VAERS ID: 1716042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle pain; Dizziness; Joint pain; Fever; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25923299) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included PARACETAMOL from 11-Aug-2021 to 16-Aug-2021 for COVID-19 treatment. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) had not resolved and DIZZINESS (Dizziness), ARTHRALGIA (Joint pain) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information were reported. Patient is not enrolled in clinical trial. Company Comment: This case concerns a female subject, of unknown age, with no relevant medical history, who experienced the unexpected events of dizziness, mylagia, arthralgia and pyrexia. The events occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The events mylagia, arthralgia and pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, all events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.; Sender''s Comments: This case concerns a female subject, of unknown age, with no relevant medical history, who experienced the unexpected events of dizziness, mylagia, arthralgia and pyrexia. The events occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The events mylagia, arthralgia and pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Of note, all events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.


VAERS ID: 1716046 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201121; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Taste metallic; Numbness in leg; This case was received via the RA (Reference number: GB-MHRA-ADR 25923961) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic) and HYPOAESTHESIA (Numbness in leg) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 21-Nov-2020. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced DYSGEUSIA (Taste metallic) (seriousness criterion medically significant) and HYPOAESTHESIA (Numbness in leg) (seriousness criterion medically significant). At the time of the report, DYSGEUSIA (Taste metallic) and HYPOAESTHESIA (Numbness in leg) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company comment- This case concerns a 25 year old male patient with a history of COVID-19, who experienced the unexpected event of Dysgeusia and Hypoaesthesia. The events occurred the same day after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The events are considered related to the product. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report; Sender''s Comments: This case concerns a 25 year old male patient with a history of COVID-19, who experienced the unexpected event of Dysgeusia and Hypoaesthesia. The events occurred the same day after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The events are considered related to the product. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report


VAERS ID: 1716047 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Maternal exposure during pregnancy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Headache; Maternal exposure during pregnancy; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 25924562) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation, ASPIRIN from 09-Sep-2021 to an unknown date for In vitro fertilization. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 10-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was exposed to the medicine first-trimester (1-12 weeks). Patient result of scans or investigations were normal. No treatment information was provided by the reporter. This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events nausea, headache, and Maternal exposure during pregnancy. Patient was exposed to the vaccine in first trimester (1-12 weeks). The events nausea and headache occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected events nausea, headache, and Maternal exposure during pregnancy. Patient was exposed to the vaccine in first trimester (1-12 weeks). The events nausea and headache occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1716050 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-09-09
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Inappropriate schedule of vaccine administered; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25925248) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 09-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. There was no concomitant medication reported. There was no treatment medication reported. Company Comment - This case concerns an 18 year-old female subject with no reported medical history who experienced the unexpected events of pyrexia and inappropriate schedule of vaccine administration. The onset of event pyrexia is incorrectly captured as occurring after the first dose, whereas it occurred 1 day after the second dose. The rechallenge was unknown as there is no information about the first dose. The event of pyrexia is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns an 18 year-old female subject with no reported medical history who experienced the unexpected events of pyrexia and inappropriate schedule of vaccine administration. The onset of event pyrexia is incorrectly captured as occurring after the first dose, whereas it occurred 1 day after the second dose. The rechallenge was unknown as there is no information about the first dose. The event of pyrexia is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1716059 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Hypotension, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: diarrhea; Low blood pressure; fever; Fainting; This case was received via RA (Reference number: GB-MHRA-ADR 25927848) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), DIARRHOEA (diarrhea), HYPOTENSION (Low blood pressure) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In September 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced SYNCOPE (Fainting) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DIARRHOEA (diarrhea) (seriousness criterion hospitalization), HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization) and PYREXIA (fever) (seriousness criterion hospitalization). On 09-Sep-2021, SYNCOPE (Fainting) had resolved. At the time of the report, DIARRHOEA (diarrhea) and PYREXIA (fever) was resolving and HYPOTENSION (Low blood pressure) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Additional treatment medications included were more fluids and paracetamol. On unknown date, the patient had an additional test performed that included a blood test (good) Patient had experience lost vision, lost concisions, the morning after the second dose of vaccination The ambulance arrived and patient was treated with fluids. During the night patient had a lot of fever. When patient regained conscious 1 min later, had vomited and had diarrhea. At the hospital blood pressure was still low. Company Comment: This case concerns an unknown age and gender, with no relevant medical history, who experienced the unexpected events of syncope, diarrhea, hypotension and pyrexia. The event occurred approximately on an unknown date after receiving the second dose of the Moderna covid-19 vaccine. The event was considered related. The benefit-risk relationship of drug mRNA-1273, is not affected by this report.; Reporter''s Comments: This case concerns a SUBJECT AGE year-old, male/female subject with a history of XXX (include only the current and historical conditions relevant for causality), who experienced the expected / unexpected (labeled/not labeled) event/s of EVENT/s (relevant SAE/s and/or AESI/s and/or cause/s of death, use PT or appropriately written verbatim term). The event occurred prior to study drug administration OR The event occurred approximately TIME TO ONSET FROM FIRST DOSE after the first dose of and TIME TO ONSET FROM subsequent (specify SECOND and/or THIRD DOSE after the most recent dose of . The rechallenge was positive/negative/unknown/not applicable (provide the reason e.g. IP was continued) for event of XX (include here only if multiple dose data and subsequent events are available and/or supports the causality, otherwise move to the end as confounders). The event was considered related/unrelated to the study drug per the reporter''s assessment (include if causality is provided by the reporter). The event is consistent with the current understanding of the mechanism of action of the study medication (use it only if applicable). The medical history, of XX, concurrent events/conditions XX, use of concomitant medication XX (known to cause the event), negative rechallenge remain/remains a confounder/confounders (include only relevant for causality).The benefit-risk relationship of drug x in not affected by this report; Sender''s Comments: This case concerns an unknown age and gender, with no relevant medical history, who experienced the unexpected events of syncope, diarrhea, hypotension and pyrexia. The event occurred approximately on an unknown date after receiving the second dose of the Moderna covid-19 vaccine. The event was considered related. The benefit-risk relationship of drug mRNA-1273, is not affected by this report.


VAERS ID: 1718919 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210937828

Write-up: MYOCARDITIS; This spontaneous report received from a physician via a Regulatory Authority (DE-PEI-202100190498) on 20-SEP-2021 and concerned a 21 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: UNKNOWN) dose was not reported, 1 total administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced myocarditis and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).


VAERS ID: 1720822 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-09-09
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210504; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101190793

Write-up: Pericarditis; This is a spontaneous report from a contactable physician received from the Regulatory authority report number GB-MHRA-WEBCOVID-202109091017492680-I1PMG, Safety Report Unique Identifier GB-MHRA-ADR 25917004. A 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. On 09Sep2021 the patient experienced pericarditis. The events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04May2021. Outcome of Event was Not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190732

Write-up: Fainting; This is a spontaneous report from a contactable other-healthcare professional. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109091656105910-QFBXD. Safety Report Unique Identifier GB-MHRA-ADR 25919305. A male patient of an unspecified age received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for Injection, Batch/Lot Number: FF2153), via an unspecified route of administration on 09Sep2021, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route, on an unknown date, as single dose for COVID-19 immunization. On 09Sep2021, the patient experienced fainting, which got resolved on the same day. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720852 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Headache, Lethargy, Nausea, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:39.4; Comments: temperature 39.4 up to now; Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101190735

Write-up: nauseous; sore throat; dizzy; shaking; runny nose; lethargic; massive headache; sore feet; aching from head to toe; High temperature; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109092153092410-MEV4Z, Safety Report Unique Identifier GB-MHRA-ADR 25920745. A 41-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Fe8087), dose 2 via an unspecified route of administration on 09Sep2021 (at the age of 41-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient experienced nauseous on an unspecified date, sore throat on an unspecified date, dizzy on an unspecified date, shaking on an unspecified date, runny nose on an unspecified date, lethargic on an unspecified date, massive headache on an unspecified date, high temperature on 09Sep2021, sore feet on an unspecified date, aching from head to toe on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 39.4 on temperature 39.4 up to now , sars-cov-2 test: positive on 27Dec2020 Yes - Positive COVID-19 test. Massive headache, sore throat, runny nose, aching from head to toe, shaking, temperature 39.4 up to now. Dizzy, nauseous, sore feet, extremely lethargic. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1720853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-09-09
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190738

Write-up: bleeding; Prolonged periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109092153293630-YM4JR, Safety Report Unique Identifier GB-MHRA-ADR 25920751. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FE1510), via an unspecified route of administration on 02Aug2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced bleeding and on 09Sep2021, the patient experienced prolonged periods. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient had her period for the usual amount of time. Her period had finished and three days later have started bleeding again. This has never happened before. Patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the event bleeding was recovering and for the event prolonged periods it was not recovered. No follow up attempts are needed. No further information is expected.


VAERS ID: 1720858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRANEXAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy periods
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202101190661

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109092232263900-RQFG6, Safety Report Unique Identifier GB-MHRA-ADR 25921026. A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Sep2021 (Batch/Lot Number: FE8087) as a single dose for COVID-19 immunisation. Medical history included heavy periods. Concomitant medication included tranexamic acid taken for heavy menstrual bleeding from 2013. The patient previously took first dose of BNT162B2 on an unknown date for covid-19 immunisation. On 09Sep2021, the patient experienced heavy periods. On an unknown date, the patient underwent sars-cov-2 test resulted in negative. The patient had her period come early and it is very very heavy, even with blood clotting medication she was bleeding far more than she ever previously did. She was filling up nightly pads which were meant for 8 hours, in 1-2 hours. Patient had not tested positive for COVID-19 since having the vaccine and patient was not enrolled in clinical trial. The outcome of the event was not recovered. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1720882 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-09
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Inappropriate schedule of product administration, Myalgia, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: muscle aches; Swelling; Fatigue; Joint ache; Shivers; Fever; Inappropriate schedule of vaccine administered; This case was received via regulatory authority (Reference number: WEBCOVID-202109121619467920-VFB9S) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), CHILLS (Shivers), PYREXIA (Fever), FATIGUE (Fatigue), ARTHRALGIA (Joint ache) and MYALGIA (muscle aches) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3004223 and 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 04-Jun-2020. Concomitant products included IBUPROFEN from 08-Dec-2020 to 24-Jun-2021 for Pericarditis. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Sep-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On 11-Sep-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (muscle aches) (seriousness criterion medically significant). On 10-Sep-2021, PYREXIA (Fever) and ARTHRALGIA (Joint ache) had resolved. On 11-Sep-2021, CHILLS (Shivers) had resolved, FATIGUE (Fatigue) was resolving. At the time of the report, SWELLING (Swelling) had not resolved, MYALGIA (muscle aches) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. On 11-Sep-2021, patient experienced swelling of armpit and arm near injection site and it worsened on 12-Sep-2021. On an unknown date, the patient felt her am was hot to the touch and painful. Armpit is painful - dull ache. No treatment medication information was mentioned by reporter. Company Comment: This case concerns a 34-year-old, female patient with had underlying medical history of suspected Covid-19, who experienced the unexpected events of swelling, chills, pyrexia, fatigue, arthralgia and myalgia. The event chills happened the same day of the second dose of the vaccine, the rest of the events occurred 2 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 34-year-old, female patient with had underlying medical history of suspected Covid-19, who experienced the unexpected events of swelling, chills, pyrexia, fatigue, arthralgia and myalgia. The event chills happened the same day of the second dose of the vaccine, the rest of the events occurred 2 days after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1722131 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Syncope; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP092475) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21126403). Syncope was assessed as serious by the Regulatory Authority. On an unknown date, body temperature before vaccination: 36.7 degrees Celsius. On 09-Sep-2021, in the afternoon, the patient received the 1st dose of this vaccine. At 14:30, vasovagal reflex developed after vaccination. The patient experienced nausea, dizziness, and dyspnoea, followed by syncope. The patient was followed up with leg elevation and was in remission. The outcome of vasovagal reflex and syncope was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 23-year-old, female patient with no relevant medical history who experienced the unexpected event of Syncope. The event occurred on the same day after administration of the first dose of mRNA-1273. The rechallenge was not applicable as the event happened after the first dose. The reporter assessed the events as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1722132 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Syncope; Vasovagal reflex; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP092482) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the RA (Ref,v21126401). Syncope was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 09-Sep-2021, in the afternoon, the patient received the 1st dose of the vaccine. While under observation, the patient experienced vasovagal reflex. The patient experienced syncope and fell from a chair. Thereafter, the patient recovered with leg elevation. There was a remission of the symptom. The outcome of vasovagal reflex and syncope was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 25 year-old female subject with no reported medical history who experienced the unexpected event of syncope. The event occurred approximately 1 day after the first dose of mRNA-1273. The rechallenge was not applicable as only information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1724445 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SC

Administered by: Public       Purchased by: ?
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxone (synthroid)
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Developed ?Covid Arm? 7 days post-vaccination. Noticed a red patch of skin, approximately 4cm in Diameter at the injection site. Minimal inflammation, itchy, no pain. I did not use any antihistamines, no topical ointments, etc. Red spot disappeared within two days. Aside from a minimally sore deltoid the day following the vaccine, I experienced no other side effects. I am still waiting to receive my second dose in the series.


VAERS ID: 1724433 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Nausea, Pallor, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM HYDROCHLORIDE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191472

Write-up: Syncope; Lost consciousness; Nausea; pale; Shaking; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00260194, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25919034. A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: FE3380) via intramuscularly, administered in left deltoid on 09Sep2021 (at the age of 20 years old) as 0.3 mL single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included citalopram hydrochloride and ethinylestradiol, levonorgestrel (RIGEVIDON); both taken for an unspecified indication, start and stop date were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: not reported) via unspecified route of administration on unknown date as single dose for COVID-19 immunisation and had no reaction. Patient reports no immediate complications or reactions following first dose of vaccine, but she did have the vaccine administered whilst she was lying down. On 09Sep2021 (within a few seconds of vaccination), patient experienced syncope (medically significant), lost consciousness (medically significant) nausea, pale and shaking. Patient felt very faint, became pale, and she briefly lost consciousness for a few seconds. During this period the patient was noted to be shaking. Patient made a full recovery within 2 minutes. Syncopal episode was considered to be a moderately severe reaction. The outcome of all events was resolved on 09Sep2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Derealisation, Feeling abnormal, Hot flush, Hyperhidrosis, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101190652

Write-up: sweaty; Fuzzy head; Derealisation; Hot flush; Shakiness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109091155328900-B5AKP. Safety Report Unique Identifier [GB-MHRA-ADR 25917593]. A 23-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Sep2021 (Batch/Lot Number: FE3380) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included (BNT162B2), via an unspecified route of administration on unknown date for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. The patient experienced sweaty on an unspecified date, fuzzy head on an unspecified date, derealisation on 09Sep2021, hot flush on 09Sep2021, shakiness on 09Sep2021. 1. Derealisation- I feel like I am not here but I am, and I have to focus extra hard on family activities because I feel extremely spaced out. 2. Hot flush- comes and goes, I get hot and sweaty. 3. Shakiness- my muscles feel like they are shaky, but no shaking can be seen. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724623 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cold sweat, Dyspnoea, Electrocardiogram, Respiratory distress, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190675

Write-up: clammy; shaking; struggling to breathe; distressed; Chest pain; This is a spontaneous report from a contactable Other Health Professional. This report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109091959182760-HAFEW. Safety Report Unique Identifier GB-MHRA-ADR 25920232. A patient of unspecified age and gender received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 09Sep2021 (Batch/Lot Number: FF2153) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced clammy, shaking, struggling to breathe and distressed. On 09Sep2021, the patient had chest pain. Patient had no symptoms associated with COVID-19. Patient presented with crushing chest pain and struggling to breathe soon after having his first dose of Pfizer vaccination. Assisted to emergency pod where clinically assessed by clinical supervisor. Patient unable to communicate in full sentences, continued to struggle to breathe grabbing his chest, pain scale 10/10, started shaking uncontrollably and kept saying he could not breathe, patient was cold and clammy to touch. Patient appeared very frightened and distressed. Ambulance called and decision was made to administer 0.5 adrenaline. Adrenaline administered to right thigh at 17:58 and patient was still distressed and continued to be in pain, constant reassurance and breathing techniques encouraged. The second dose adrenaline prepared but not administered as symptoms reduced. Chest pain still evident according to patient. Paramedics arrived at 18:10 assessed the patient preformed electrocardiogram (ECG) and took control of the situation. Confirmed that the appropriate treatment was given. Took patient to hospital for further investigations. Patient was able to mobilise. Necessary documentation completed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible blood clots or low platelet counts. The patient underwent SARS-CoV-2 test which showed negative, electrocardiogram results was unknown. Therapeutic measures were taken as a result of the event distressed. The outcome of the events clammy, shaking and chest pain was recovering and for the events struggling to breathe and distressed the outcome was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-09
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101190585

Write-up: Pain; Dead arm; Extreme pain when lifting arm; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109092115216790-ZAZCV with Safety Report Unique Identifier GB-MHRA-ADR 25920608. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 17Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from an unknown date to an unknown date; it was unsure when symptoms had started and stopped. The patient was not enrolled in the clinical trial. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced extreme pain on lifting arm and dead arm. On 09Sep2021, the patient experienced pain. The events were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date, the patient underwent COVID-19 virus test and the result was No - Negative COVID-19 test. The clinical outcome of the event pain was not recovered whereas that of the events extreme pain when lifting arm and dead arm was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191590

Write-up: Palpitations; Shortness of breath; This is a spontaneous report from a contactable health care professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202109101039047010-ESIUZ; Safety Report Unique Identifier: GB-MHRA-ADR 25923121. A 31-year-old male patient received Bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not known) via an unspecified route of administration on 07Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 09Sep2021, patient experienced shortness of breath. On 10Sep2021, the patient experienced palpitation. The patient was sent to hospital. The events were assessed as medically significant. The outcome of the events were not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724647 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Inappropriate schedule of product administration, SARS-CoV-2 test, Vaccination site pain
SMQs:, Arthritis (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191746

Write-up: Fatigue; Joint ache; Injection site pain; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other hcp. This report is received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101228553600-BRVOA. Safety Report Unique Identifier GB-MHRA-ADR 25923737. A 30-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Batch/Lot Number: FF2153), dose 2 via an unspecified route of administration on 09Sep2021 was dose 2, single (at the age of 30 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Batch/Lot Number: FD8813), dose 1 via an unspecified route of administration on 10Jul2021 was dose 1, single for COVID-19 immunization. On 09Sep2021 the patient experienced injection site pain (vaccination site pain), and Inappropriate schedule of vaccine administered. On 10Sep2021 the patient had fatigue, joint ache. The patient underwent lab tests and procedures which included SARS-CoV-2 test was negative covid-19 test on 06Sep2021 No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. The patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. The outcome of event (Inappropriate schedule of vaccine administered) was unknown and rest of all events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724669 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Palpitations, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200407; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101191713

Write-up: Tiredness; Vomiting; Nausea; Palpitations; Pain in arm; Headache; This is a spontaneous report from a contactable consumer. These was a report received from theRegulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101722598110-LDAMC,Safety Report Unique Identifier(GB-MHRA-ADR 25925176). A 32-years-old female patient non-pregnant received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FF2153) via an unspecified route of administration, administered on 09Sep2021 at the age of (32-years-old) as dose 2, single for covid-19 immunisation. Medical history included suspected covid-19 from 02Apr2020 to 15Apr2020. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered on unspecified date as a single dose for covid-19 Immunisation. It was reported that on 09Sep2021 the patient experienced vomiting, nausea, palpitations, pain in arm, headache.On 10Sep2021 the patient experienced tiredness. Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. On 07Apr2020 the patient underwent lab tests and procedures which included covid-19 virus test which was resulted as positive (Positive COVID-19 test). The patient was recovering from the events of vomiting, palpitations. The patient was not recovered from the events of nausea, pain in arm, tiredness, headache at the time of report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724694 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Headache, Insomnia, Myalgia, Nausea, Pain, Photophobia, Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: Within 5 hours of vaccine, felt feverish, measured 39C on forehead.; Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191602

Write-up: nauseous; feverish; do not know if recovered fully; within 5 hours of vaccine; tiredness; soreness around injection site persists; Vomiting; Nausea; Fever; Ache; Muscle soreness; Insomnia; Headache; General body ache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109110804493570-IOPSZ. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25927675. A 20-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FF2153) via an unspecified route of administration on 09Sep2021 (at age of 20-years-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on unknown date as single dose for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date patient experienced nauseous, feverish, do not know if recovered fully, within 5 hours of vaccine, tiredness. On 09Sep2021 (after 1 day of vaccination), patient experienced vomiting, nausea, fever, ache, muscle soreness, insomnia, headache started within 5 hours of vaccination, soreness around injection site persists started within an hour of vaccination, persists but lessening, general body ache started within 5 hours of vaccination. Within 5 hours of vaccine, felt feverish, measured 39C on forehead. Took paracetamol to relieve fever, every 8 hours roughly for 2 days. Temperature stayed above 38C throughout. Shortly before taking paracetamol, felt nauseous. Nausea led to vomiting contents of earlier food. Could not keep solid food down. Headache was dull. Not quite migraine-like. Insomnia has caused major sleep disruption issues, though can''t say how much of it is affected by vomiting and how much was pure insomnia. Tiredness too. Don''t know if recovered fully, because haven''t had a full sleep yet. Noted as not recovered due to this. Lab tests on 09Sep2021, included negative COVID-19 virus test and body temperature was 39 centigrade. The outcome of events vomiting, nausea, fever, ache, general body ache was resolved on 11Sep2021, muscle soreness was resolving and all other events were not resolved. No follow-up attempts are needed. No further information is expected.


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